Standard ICS number:Sociology, Services, Organization and management of companies (enterprises), Administration, Transport>>Quality>>03.120.10 Quality management and quality assurance
Standard Classification Number:General>>Standardization Management and General Regulations>>A00 Standardization, Quality Management
drafter:Li Renliang, Li Jing, Gu Su, Chen Deyao, He Shukui, Zhang Yinping, Xu Wenzheng, Wang Linlin
Drafting unit:China National Institute of Standardization, Beijing Institute of Automation and Control Equipment, etc.
Focal point unit:National Technical Committee on Quality Management and Quality Assurance Standardization (SAC/TC 151)
Proposing unit:National Technical Committee on Quality Management and Quality Assurance Standardization (SAC/TC 151)
Publishing department:General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
This standard is one of the GB/T19000 family of standards. This standard replaces GB/T19017-1997 "Guidelines for Technical Status Management of Quality Management". This standard provides guidance for technical status management within an organization and is applicable to all stages of supporting products from concept to disposal. This standard first specifies the responsibilities and authorities for implementing technical status management, and secondly describes the process of technical status management, including technical status management planning, technical status identification, change control, technical status recording and technical status review. This standard is a guidance document and is not intended for certification purposes. Compared with the standard it replaces, this standard has the following changes: --- In terms of terminology, five terms in the original standard are retained and their definitions are modified accordingly, while four terms such as change control, concession, management organization and product technical status information are added; --- In terms of the structure of the standard, the chapter "Technical Status Management Organization" in the original standard is deleted to no longer emphasize that the organization must specify the organizational structure of technical status management; --- In terms of the content of the standard, the technical status document is deleted, and the new concept of "product technical status information" is proposed, emphasizing that although the organization does not have to specify the organizational structure of technical status management, it should determine and describe the responsibilities and authorities for implementing and verifying the relevant technical status management processes; --- In terms of the appendix of the standard, Appendix B and Appendix C in the original standard are deleted. GB/T 19017-2008 Guide to Technical Status Management of Quality Management Systems GB/T19017-2008 Standard download decompression password: www.bzxz.net
This standard is one of the GB/T19000 family of standards. This standard replaces GB/T 19017-1997 "Guidelines for Technical Status Management of Quality Management". This standard provides guidance for technical status management within an organization and is applicable to all stages of supporting products from concept to disposal. This standard first specifies the responsibilities and authorities for implementing technical status management, and secondly describes the process of technical status management, including technical status management planning, technical status identification, change control, technical status recording and technical status review. This standard is a guidance document and is not intended for certification purposes. Compared with the standard it replaces, this standard has the following changes:
———In terms of the terminology of the standard, 5 terms in the original standard are retained and the definitions of these terms are modified accordingly. At the same time, 4 terms such as change control, concession, management organization and product technical status information are added;
———In terms of the structure of the standard, the chapter "Technical Status Management Organization" in the original standard is deleted to no longer emphasize that the organization must specify the organizational structure of technical status management;
———In terms of the content of the standard, the technical status document is deleted, and the new concept of "product technical status information" is proposed, emphasizing that although the organization does not have to specify the organizational structure of technical status management, it should determine and describe the responsibilities and authorities for implementing and verifying the relevant technical status management processes;
———In terms of the appendix of the standard, Appendix B and Appendix C in the original standard are deleted .
This standard is one of the GB/T19000 family of standards.
This standard is equivalent to ISO10007:2003 "Guidelines for Technical Status Management of Quality Management Systems".
This standard replaces GB/T19017-1997 "Guidelines for Technical Status Management of Quality Management".
Compared with the standard it replaces, this standard has the following major changes:
---In terms of the terminology of the standard, five terms in the original standard are retained and the definitions of these terms are modified accordingly, and four terms such as change control, concession, management organization and product technical status information are added;
---In terms of the structure of the standard, the chapter on technical status management organization in the original standard is deleted to no longer emphasize that the organization must specify the organizational structure of technical status management;
---In terms of the content of the standard, the technical status document is deleted, and a new concept of product technical status information is proposed, emphasizing that although the organization does not have to specify the organizational structure of technical status management, it should determine and describe the responsibilities and authorities for implementing and verifying the relevant technical status management processes;
---In terms of the appendix of the standard, Appendix B and Appendix C in the original standard are deleted.
Appendix A of this standard is an informative appendix.
This standard is proposed and managed by the National Technical Committee for Standardization of Quality Management and Quality Assurance (SAC/TC151).
This standard is drafted by the China National Institute of Standardization.
Participating drafting units of this standard: Beijing Automation Control Equipment Research Institute, 719th Institute of China Shipbuilding Industry Corporation, Beijing Institute of Aeronautical Materials of China First Aviation Group Corporation, China Aviation Comprehensive Technology Research Institute, China Nuclear Industry Standardization Institute, China Aerospace Standardization Institute.
Main drafters of this standard: Li Renliang, Li Jing, Gu Su, Chen Deyao, He Shukui, Zhang Yinping, Xu Wenzheng, Wang Linlin.
The previous versions of the standards replaced by this standard are:
---GB/T19017-1997. The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version is applicable to this standard.
GB/T19000-2000 Quality Management System Fundamentals and Vocabulary (ISO9000:2000, IDT) Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Responsibilities for technical status management 2
4.1 Responsibilities and authorities 2
4.2 Management organization 2
5 Technical status management process 2
5.1 General 2
5.2 Technical status management planning 2
5.3 Technical status identification 3
5.4 Change control 3
5.5 Technical status record 4
5.6 Technical status audit 5
Appendix A (Informative) Structure and content of the technical status management plan 6
References 8
Some standard content:
ICS03.120.10 National Standard of the People's Republic of China GB/T19017--2008/IS010007:2003 replaces GB/T19017--1997 Quality management systems Guidelines for configuration management(ISO10007:2003IDT) Published on May 7, 2008 General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Digital Anti-counterfeiting Standardization Administration of the People's Republic of China 2008-12-01Implementation This standard is one of the GB/T19000 family of standards GB/T190172008/IS010007.2003 This standard is equivalent to ISO10007:2003 "Guidelines for Technical Status Management of Quality Management Systems". This standard replaces GB/T19017-1997 "Guidelines for Technical Status Management of Quality Management". Compared with the standard it replaces, this standard has the following changes: In terms of terminology, five terms in the original standard are retained and their definitions are modified accordingly, while four terms such as change control, concession, management organization and product technical status information are added; In terms of the structure of the standard, the chapter "Technical Status Management Organization" in the original standard is deleted to no longer emphasize that the organization must specify the organizational structure of technical status management; In terms of the content of the standard, the technical status document is deleted, and the new concept of "product technical status information" is proposed, emphasizing that although the organization does not necessarily have to specify the organizational structure of technical status management, it should determine and describe the responsibilities and authorities for implementing and verifying the relevant technical status management process; In terms of the appendix of the standard, Appendix B and Appendix C in the original standard are deleted. Appendix A of this standard is an informative appendix. This standard is proposed and managed by the National Technical Committee for Quality Management and Quality Assurance (SAC/TC151). This standard is initiated by the China National Institute of Standardization. The drafting organizations of this standard include: Beijing Automation Control Equipment Research Institute, 719th Research Institute of China Shipbuilding Industry Corporation, Beijing Institute of Aeronautical Materials of China First Aviation Corporation, China Aviation Comprehensive Technology Research Institute, China Nuclear Industry Standardization Research Institute, China Aerospace Standardization Research Institute. The main drafters of this standard include: Li Renliang, Li Jing, Gu Su, Chen Deyao, He Shukui, Zhang Yinping, Xu Wenzheng, Wang Linlin. The previous versions of the standards replaced by this standard are: GB/T19017-1997. GB/T19017—2008/ISO10007:2003 Introduction This standard aims to enhance people's understanding of technical status management, promote the use of technical status management, and help organizations apply technical status management to improve their performance. Technical status management is an activity to manage technical status items and related product technical status information throughout the product life cycle using technical and administrative means. Technical status management is to document the technical status of the product and provide a way to identify and trace the realization of the physical and functional requirements of the product and accurately obtain information at all stages of the product life cycle. Organizations can implement technical status management according to their size and the complexity and nature of their products. Technical status management can be used to meet the product identification and traceability requirements specified in GB/T19001. IV 1 Scope Quality management system GB/T19017—2008/IS010007:2003 Technical status management guide This standard provides guidance for technical status management within an organization and is applicable to all stages of supporting products from concept to disposal. This standard first specifies the responsibilities and authorities for implementing technical status management, and secondly describes the process of technical status management, including technical status management planning, technical status identification, change control, technical status recording and technical status review. This standard is a guidance document and is not intended for certification purposes. 2 Normative references The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated references, the latest versions apply to this standard. GB/T19000--2000 Quality Management System Fundamentals and Vocabulary (ISO9000.2000, IDT) 3 Terms and Definitions The terms and definitions established in GB/T19000--2000 and the following terms and definitions apply to this standard. 3.1 change controlchangecontrol Control activities on products after the product technical status information (3.9) has been formally approved3.2 concession Permission to use or release a product that does not conform to specified requirementsNote 1: Concessions are usually limited to the delivery of a product with nonconforming characteristics within an agreed time or quantity, [GB/T19000-2000, definition 3.6.11]Note 2: Concessions do not affect the technical status baseline (3.4) and include permission to produce products that do not conform to specified requirements.Note 3: Some organizations use the term "concession" or "deviation" instead of "concession". 3.3 configuration the interrelated functional and physical characteristics of a product as specified in the product configuration information (3.9) 3.4 configuration baselineconfiguration baseline product configuration information (3.9) established and approved at a point in time and used as a reference for activities throughout the product life cycle 3.5 configuration itemconfiguration item an entity within a configuration (3.3) that satisfies an end-use function 3.6 configuration managementconfiguration management the coordination of activities to direct and control the configuration NOTE Configuration management typically focuses on the technical and organizational activities involved in establishing and maintaining control of a product and its product configuration information (3.9) throughout the product life cycle GB/T190172008/ISO10007:2003 configuration statusaccounting Formal record and report of product configuration information (3.9), proposed changes and implementation of approved changes 3.8 Management body dispositioningauthority A person or group of people who is given the responsibility and authority to make decisions on the technical status (3.3) Note 1: The management body can also be called the "technical status committee". Note 2: The management body should include representatives of relevant parties inside and outside the organization. 3.9 Product configuration informationproductconfigurationinformationRequirements for product design, implementation, verification, operation and support4 Configuration management responsibilities 4.1 Responsibilities and authorities The organization shall determine and describe the responsibilities and authorities for implementing and verifying the relevant configuration management processes, taking into account the following aspects: - the complexity and nature of the product; - the requirements at different stages of the product life cycle; - the interfaces between the various activities involved in the configuration management process; - other stakeholders that may be involved within and outside the organization; - the determination of the responsible department for verifying the implementation activities; the determination of the management body. 4.2 Management body Before approving a change, the management body shall verify that: the proposed change is necessary and the result is acceptable; the change has been appropriately documented and classified; and the activities planned for implementing the change in documents, hardware and/or software are satisfactory. 5 Configuration management process 5.1 General The activities carried out in the configuration management process are described in the following clauses. In order for this process to be effective, coordination of these activities is essential. The configuration management process should focus on customer requirements for the product and should consider the context of the activities performed. The configuration management process should be detailed in the configuration management plan, describing the specific procedures and their scope of application for any item in the product life cycle. 5.2 Technical configuration management planning Technical configuration management planning is the basis of the technical configuration management process. Effective planning is the coordination of technical configuration management activities in a specific situation throughout the product life cycle. The output of technical configuration management planning is the technical configuration management plan. For a specific product, the technical configuration management plan should: be documented and approved; be controlled; -determine the technical configuration management procedures to be used;-reference the relevant procedures of the organization as much as possible;-specify the responsibilities and authorities for carrying out technical configuration management throughout the product life cycle. 2 GB/T19017—2008/IS010007:2003The technical configuration management plan can be a separate document, or part of other documents, or composed of several documents. In some cases, the organization may require the supplier to provide a technical configuration management plan, which can be used as a separate document or included in its own technical configuration management plan. The possible structure and content of the technical configuration management plan can be found in Appendix A. 5.3 Technical Status Identification 5.3.1 Product Structure and Selection of Technical Status Items The selected technical status items and their interrelationships shall describe the product structure. The organization shall determine the technical status items based on the established selection criteria. The organization shall select those items as technical status items whose functional characteristics and physical characteristics can be managed separately to achieve the full end-use performance of the technical status item. The selection criteria shall consider: Legal and regulatory requirements; Degree of hazard from the perspective of risk and safety;--New or improved technology, design or development;+\Interfaces with other technical status items; Procurement conditions; Support and service. The number of technical status items selected shall consider maximizing the organization's ability to control the product. The selection of technical status items shall begin early in the product life cycle. As the product progresses, the technical status items shall be reviewed. 5.3.2 Product Technical Status Information Product technical status information includes the definition of the product and information on the use of the product, usually including: requirements, specifications, design drawings, parts lists, software documents and lists, models, test specifications, maintenance and operation manuals. Product status information shall be relevant and traceable. The organization shall determine a unique numbering scheme to ensure appropriate control of each status item and shall take into account the organization's existing numbering practices, as well as change control information, such as modification status. 5.3.3 Status Baseline The status baseline consists of the approved product status information that describes the product definition. The status baseline, plus changes to these approved baselines, represents the current valid status. Status baselines shall be established as needed during the product life cycle to provide a baseline for subsequent activities. The level of detail in which the product is defined in the status baseline depends on the level of control required. 5.4 Change Control 5.4.1 General All changes to product status information after initial release shall be controlled. The potential impact of the change, customer requirements and the status baseline will influence the level of control required to handle a proposed change or concession. The process for controlling changes shall be documented and shall include the following: - description of changes, reasons for changes and records; - categories of changes determined by complexity, resources and schedule; - evaluation of the consequences of changes; - details of how changes are handled; - details of how changes are implemented and verified. 5.4.2 Proposal, identification and documentation of required changes Changes may be initiated by the organization, a customer or a supplier. All proposed changes shall be identified and documented before evaluation by the management (see 4.2). Proposed changes shall normally include the following information: - technical status items to be changed and related information, including their titles and details of the current modification status: 3 GB/T19017--2008/IS010007:2003 - description of the proposed change - details of other technical status items or information that may be affected by the change; the interested parties proposing the change and the date of the proposal; the reasons for the change; - category of change. The status of change handling, related decisions and arrangements shall be documented. For ease of identification and traceability, change documents can usually use a standard form and assign a unique identification number. 5.4.3 Evaluation of changes 5.4.3.1 The organization shall evaluate and document the proposed changes. The scope of any evaluation shall depend on the complexity of the product and the type of change, and shall include the following: - The technical advantages of the proposed change; - The risks associated with the change; - The potential impact on the contract, schedule and cost. 5.4.3.2 When determining the impact, the following factors shall also be considered: - Relevant legal and regulatory requirements; - The interchangeability of technical status items and the need to re-identify them; - Interfaces between technical status items; - Manufacturing, testing and inspection methods; Inventory and procurement; Delivery activities; - Customer support requirements. 5.4.4 Handling of changes For the handling of changes, a process should be established to identify the management body for each change proposal (see 4.2). At the same time, the category of change proposals should be considered. After the change proposal is evaluated, the management body shall review the evaluation and make a decision on the handling of the change. The handling of the change shall be recorded and all interested parties within and outside the organization shall be notified. 5.4.5 Implementation and verification of changes The implementation of approved changes usually includes: - Release of the changed product technical status information to the interested parties: - Actions taken by the interested parties (within and outside the organization) affected by the change. After the change is implemented, the conformity of the approved change shall be verified. This verification shall be recorded for traceability. 5.5 Technical status documentation 5.5.1 General The technical status documentation activities generate records and reports related to the product and the product technical status information. The organization shall carry out technical status documentation activities throughout the product life cycle to support the technical status management process and make it effective. 5.5.2 Records 5.5.2.1 Technical status records will be generated during the technical status identification and change control activities. Considering the review and traceability as well as the effective management of the changing technical status, these records usually include the following details: - Product technical status information (for example: identification number, title, effective date, modification status, change history, and the content included in any baseline); - Product technical status (for example: part number, product design or manufacturing status); the status of the release of new product technical status information; the handling of changes. bzxz.net GB/T19017—2008/IS010007:20035.5.2.2 In order to provide the required reports (see 5.5.3), it is necessary to record the changing product technical status information in a way that can be referenced and related to each other. 5.5.2.3 In order to protect the integrity of the product technical status information and provide a basis for controlling changes, it is recommended that the technical status items and related information be kept under the following conditions: Meet the required conditions (for example, conditions required for computer hardware, software, data, documents, drawings): provide protection to prevent damage or unauthorized changes; - Provide methods for troubleshooting; - Allow recovery. 5.5.3 Reports In order to achieve the purpose of technical status management, various types of reports are required. Such reports can cover individual technical status items or the entire product. Typically, the report includes: - A list of product technical status information contained in a specific technical status baseline; a list of technical status items and their technical status baselines; - Details of the current change status and change history; reports on changes and concessions; - Details of product delivery and maintenance status involving parts, traceability numbers and product modification status. 5.6 Technical Status Audit The technical status audit shall be conducted in accordance with documented procedures to determine whether the product meets the requirements and is consistent with the product technical status information. There are usually two types of technical status audits: Functional technical status audit. This is a formal review to verify that the technical status items have achieved the functional and performance characteristics specified in the product technical status information; Physical technical status audit. This is a formal review to verify that the technical status items have achieved the physical characteristics specified in the product technical status information. A technical status audit may be required before the formal acceptance of the technical status items. This audit is not used to replace other forms of verification, review, testing or inspection, but it may be affected by the results of these activities. 5 GB/T19017-2008/IS010007:2003 Appendix A (Informative Appendix) Structure and content of the configuration management planA.1 General The preparation of the configuration management plan should be a separate chapter under the titles A.2 to A.7 below. A.2 to A.7 also provide guidance on the content. A.2 Introduction The configuration management plan needs to give an overview in the introduction, which usually includes the content in the following titles: the purpose and scope of the configuration management plan; a description of the product and configuration items used in the plan; a progress guide based on the timetable of important configuration management activities; a description of the configuration management tools (e.g. information technology); - related documents (e.g. configuration management plan from the supplier): - a list of relevant documents and their relationships. A.3 Policy The configuration management plan should detail the configuration management policy agreed by the customer and the supplier. It should provide the basis for the technical condition management activities within the contract, such as: Policy for technical condition management and the implementation of related management activities: \· Organization, responsibilities and authorities of interested parties; \"Qualification and training; —… Criteria for the selection of technical condition items The order, distribution and control of reports to the organization and customers: Terminology. A.4 Technical condition identification The technical condition management plan should detail: —A relationship tree between technical condition items, specifications and other documents; a relationship tree between specifications, drawings, concessions and changes The numbering method used; the method of identifying the modified status; the progress of establishing the technical status baseline and the type of technical status information included: the allocation and use of serial numbers or other traceability identification; the process for publishing product technical status information. A.5 Change control The technical status management plan should detail: the relationship between the organization's management body (see 4.2) and the interested parties; the change control procedures before the technical status baseline specified in the contract is established; the method for handling changes (including those proposed by customers or suppliers) and concessions. 6 Technical status Records The technical status management plan should detail: GB/T19017—2008/IS010007:2003The methods of collecting, recording, processing and maintaining the necessary information for producing technical status records;The content and format of all technical status record reportsA.7 Technical status audit The technical status management plan should detail: The list of items to be audited within the project schedule and their arrangement;The technical status audit procedures used; —Authorities of interested parties (internal and external); Audit report GB/T19017--2008/IS010007:2003[] GB/T19001--2000 Quality Management System GB/T19004-2000 GB/T19016—-2005 Quality Management System Performance Improvement Guide Quality Management System Project Quality Management Guide ISO/IEC/TR15846:1998,Information technology-Software life cycleprocesses--Configuration Management for Software Tip: This standard content only shows part of the intercepted content of the complete standard. 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